A 510(k) is a premarket FDA requirement for low-to-medium-risk medical equipment in place of a PMA. Similar to a patent, it establishes that an original product is substantially equivalent to a legally marketed device, in terms of safety and efficacy. Obtaining a 510(k) for new medical technology can take time. However, buying one from a willing party is a fast and convenient way to market a novel device. It is also legally allowed and can take place even without FDA involvement, but it is tricky if it is not done correctly.
Availing of specialized services for buying and selling 510(k)s confers several advantages. First, expert handling of the transaction ensures it is quick, allowing manufacturers to sell a new product immediately. Second, professional treatment guarantees that the 510(k) is acquired from or transferred to trustworthy companies only. Third, consultants with regulatory expertise can assure that the exchange is free of legal and ethical complications. At VZG, we are your partners in creating innovative ways to maintain your edge in the medical device industry.
VZG offers the following 510(k) marketplace services:
- We review your document so we can help you determine its target buyers.
- With market analysis, we assist in setting the price range for the 510(k).
- We shall post the 510(k) on our website and get you in touch with the right buyers.
- We examine all pertinent information about the product, including technical specifications, clinical evidence of safety and efficacy, marketability, cost-efficiency and others.
- We perform due diligence to ensure that the 510(k) does not infringe on similar documents for other products in the market.
- VZG experts can negotiate the price for you.